Having placed their Lead QA Engineer last year, this growing technology company who operate at the intersection of healthcare, data, and advanced analytics are now looking to further build out the QA function!
If you are an experienced Software Validation Engineer looking for a new challenge, keep reading as this could be for you!
Job Title: Software Validation Engineer
Salary: Dependent on experience
Location: Cambridge or London (2 days in office, 3 days from home)
In this role, you will help ensure the delivery of high-quality products to customers operating in regulated clinical environments, while supporting compliance with relevant industry standards.
To succeed, you should have experience with automated testing frameworks, Python Automation, validating complex software systems in regulated settings, and a strong ability to identify critical issues with a high level of attention to detail.
The organisation has developed a cloud-based platform used by pharmaceutical and biotech organisations to curate and analyse clinical trial data, leveraging advanced machine learning techniques. You will contribute to the overall testing and validation strategy across a modern technology stack, including a Python-based backend, a JavaScript front end, machine learning models, and cloud infrastructure deployed on a major public cloud provider.
Key Responsibilities:
Product Development
Designing and implementing testing strategies across an integrated software platform, including automated unit, integration, regression, and end-to-end testing.
Contributing to appropriate validation approaches for components incorporating machine learning models.
Ensuring functional, performance, regulatory, privacy, and security requirements are adequately tested prior to release.
Managing test execution, including identifying, reporting, and tracking software defects.
Participating in design reviews to ensure requirements are clear, concise, and testable.
Developing repeatable, automated processes that generate traceable, audit-ready validation artefacts.
Leading or supporting risk-based computer systems validation (CSV) activities across commercial and internally developed platforms.
Ensuring compliance with clinical, quality, and regulatory standards, including Good Clinical Practice and recognised validation methodologies (e.g. GAMP 5).Quality Assurance
Proactively suggest improvements to enhance product quality and team processes.
Support external audits and demonstrate compliance with applicable standards.
Stay current with evolving best practices in testing methodologies and tools.Experience, Skills & Knowledge
Minimum 5 years’ experience in software testing, ideally within cloud-based environments.
Experience validating software in a regulated industry.
Familiarity with formal Computer Systems Validation methodologies (GAMP 5 preferred).
Experience with Python-based systems; exposure to machine learning-driven platforms is beneficial.
Proficiency with testing tools and frameworks such as pytest, Playwright, Selenium, etc., and CI/CD pipelines (e.g. Git-based systems).
Strong analytical thinking, problem-solving ability, and communication skills.Qualifications & Education
A degree in a relevant technical or scientific discipline (e.g. Computer Science, Engineering) is advantageous but not essential